LOUISVILLE, Ky. and SAN DIEGO, March 31, 2022 — USWM, LLC (US WorldMeds), and Adamis Pharmaceuticals Corporation (NASDAQ: ADMP), today announced the U.S. launch and availability of ZIMHI™ (naloxone HCL Injection, USP) 5 mg/0.5 mL. ZIMHI is a high-dose naloxone injection product FDA-approved for use in the treatment of opioid overdose as emergency therapy in settings where opioids may be present.
According to the Centers for Disease Control and Prevention (CDC), drug overdoses are now the leading cause of death for Americans under age 50, with more powerful synthetic opioids, like fentanyl and its analogs, responsible for the largest number of those deaths. Approximately 85% of all opioid overdose related deaths are now caused by fentanyl, fentanyl analogs, and other synthetic opioids. Drug overdoses resulted in over 100,000 deaths in the United States during the 12-month period ending April 2021, which was a 29% increase over the prior 12-month period.
“ZIMHI represents an important new tool for caregivers and patients by combining an intuitive, compact, and simple to use intramuscular device with a high dose of naloxone. Successfully treating overdoses involving fentanyl often requires multiple doses of lower-dose or intranasal naloxone products, creating an urgent need for new tools to help combat these more powerful opioids,” said P. Breckinridge Jones, Sr., CEO of US WorldMeds.
Dr. Dennis J. Carlo, President and CEO of Adamis, stated, “ZIMHI provides the highest intramuscular dose of naloxone among naloxone injection devices currently available. We are very excited to once again partner with US WorldMeds to launch ZIMHI. We believe that ZIMHI will play a pivotal role in the treatment of opioid overdose, while contributing positively to the entire community that has been impacted by the opioid epidemic.”
ZIMHI is available with discounted public interest pricing for first responders and other community health organizations, with additional information available via email to ZIMHIPublicHealthInfo@usworldmeds.com or at zimhi.com/public-service/.
Patient accessibility is further enhanced with a co-pay program that provides ZIMHI to eligible patients for as little as $0. Most pharmacies across the country are covered through the program with savings being automatically applied.
Physicians, pharmacists or other healthcare providers with questions about ZIMHI should visit www.zimhi.com.
ZIMHI is an opioid antagonist indicated in adult and pediatric patients for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. ZIMHI is intended for immediate administration as emergency therapy in settings where opioids may be present. ZIMHI is not a substitute for emergency medical care.
Important Safety Information for Patients
Do not use ZIMHI if you are allergic to naloxone hydrochloride or any of the ingredients in ZIMHI. ZIMHI is used to temporarily reverse the effects of opioid medicines. The medicine in ZIMHI has no effect in people who are not taking opioid medicines.
Use ZIMHI right away if you or your caregiver think signs or symptoms of an opioid emergency are present, even if you are not sure, because an opioid emergency can cause severe injury or death. Family members, caregivers, or other people who may have to use ZIMHI in an opioid emergency should know where ZIMHI is stored and how to give ZIMHI before an opioid emergency happens. Get emergency medical help right away after using the first dose of ZIMHI. Rescue breathing or CPR (cardiopulmonary resuscitation) may be given while waiting for emergency medical help.
The signs and symptoms of an opioid emergency can return within several minutes after ZIMHI is given. If this happens, give additional injections using a new ZIMHI prefilled syringe every 2 to 3 minutes and continue to closely watch the person until emergency help is received.
ZIMHI may cause serious side effects, including sudden opioid withdrawal symptoms, which may include: body aches, fever, sweating, runny nose, sneezing, goose bumps, yawning, weakness, shivering or trembling, nervousness, restlessness or irritability, diarrhea, nausea or vomiting, stomach cramping, increased blood pressure, or increased heart rate.
Other common side effects of ZIMHI include dizziness and injection site redness. In infants under 4 weeks old who have been receiving opioids regularly, sudden opioid withdrawal may be life-threatening if not treated the right way. Signs and symptoms include: seizures, crying more than usual, and increased reflexes.
These are not all of the possible side effects of ZIMHI. Call your doctor for medical advice about side effects. To report SUSPECTED ADVERSE REACTIONS, contact Adamis Pharmaceuticals Corporation at 1-858-997-2400 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Naloxone is an opioid antagonist and is generally considered the drug of choice for immediate administration for opioid overdose. It works by blocking or reversing the effects of the opioid, including extreme drowsiness, slowed breathing, or loss of consciousness. Common opioids include morphine, heroin, tramadol, oxycodone, hydrocodone and fentanyl.
About ZIMHI™ (naloxone HCL Injection, USP) 5 mg/0.5 mL
ZIMHI is a prescription medicine used in adults and children for the treatment of an opioid emergency, such as an overdose or a possible overdose with signs of breathing problems and severe sleepiness or not being able to respond. ZIMHI is to be given right away by a caregiver and does not take the place of emergency medical care. Get emergency medical help right away after the first dose of ZIMHI, even if the person wakes up.
About US WorldMeds
US WorldMeds is a privately held specialty pharmaceutical company that develops, licenses, and markets unique healthcare products designed to improve the lives of patients with challenging conditions and unmet medical needs. US WorldMeds has built a branded product portfolio in the therapeutic areas of opioid use disorder medicine, hemophilia, and malignant hyperthermia. More information on US WorldMeds can be found at www.usworldmeds.com.
About Adamis Pharmaceuticals
Adamis Pharmaceuticals Corporation is a specialty biopharmaceutical company primarily focused on developing and commercializing products in various therapeutic areas, including allergy, opioid overdose, respiratory and inflammatory disease. The Company’s SYMJEPI® (epinephrine) Injection products are approved by the FDA for use in the emergency treatment of acute allergic reactions, including anaphylaxis. The Company’s ZIMHI™ (naloxone) Injection product is approved for the treatment of opioid overdose. Tempol is in development for the treatment of patients with COVID-19 and a Phase 2/3 clinical trial is underway. For additional information about Adamis Pharmaceuticals, please visit Adamis and follow us on Twitter and LinkedIn.
Adamis Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those that express plans, anticipation, intent, contingencies, goals, targets or future development and/or otherwise are not statements of historical fact. These statements relate to future events or future results of operations, including, but not limited to the marketplace acceptance and commercial success of ZIMHI, the medical and commercial need for additional products and tools to help combat more powerful opioids, the effectiveness and success of ZIMHI in the treatment of opioid overdose, and other statements concerning Adamis’ future operations and activities. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, which may cause Adamis’ actual results to be materially different from the results anticipated by such forward-looking statements. Adamis cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. You should not place undue reliance on any forward-looking statements. Further, any forward-looking statement speaks only as of the date on which it is made, and except as may be required by applicable law, Adamis undertakes no obligation to update or release publicly the results of any revisions to these forward-looking statements or to reflect events or circumstances arising after the date of this press release. Certain of these risks and additional risks, uncertainties, and other factors are described in greater detail in Adamis’ filings from time to time with the SEC, including its most recent annual report on Form 10-K and subsequent filings with the SEC, which Adamis strongly urges you to read and consider, all of which are available free of charge on the SEC’s web site at http://www.sec.gov.
Adamis Investor Relations